Jul. 30--Despite the federal government's creation of more informative sunscreen labels, consumers can still only buy products that suggest an exaggerated degree of protection. Sunscreen defends against harmful solar rays that can damage skin and increase the risk of skin cancer.
Yet some products claim nonsensically high protection factors and undeserved degrees of water resistance.
Federal officials formulated new, more accurate labels for sunscreen in August 2007, but the U.S. Food and Drug Administration is apparently ignoring its own rules.
State Attorney General Richard Blumenthal has been pressing the agency to require sunscreen manufacturers to more accurately state a product's protective value against ultraviolet light, and resistance to water and sweat.
At issue are the usefulness of sun (or sunburn) protection factor numbers higher than 30, and claims by some manufacturers that their creams, lotions and sprays are water resistant.
Blumenthal prodded the FDA with a letter this week to Commissioner Dr. Andrew C. von Eschenbach, demanding new labeling rules be implemented.
Blumenthal, who sent similar letters in 2006 and 2007, said he will wait about a month for a response from the FDA. If none is forthcoming, the attorney general's office will probably take legal action to require the FDA to make the modifications.
What's odd, Blumenthal said, is that the FDA wrote new labeling requirements in 1999 and then didn't put them into effect.
"For far too long, sunscreen manufacturers have exploited the FDA's abject failure to enact regulations that ensure truthful, accurate claims in sunscreen advertising and labeling," Blumenthal said.
Blumenthal said he has no evidence of interference by the pharmaceutical industry that makes sunscreen, but that "big pharma" is the only group with anything to lose if the new laws are instituted.
In August 2007, the FDA proposed new standards for formulating, testing and labeling over-the-counter sunscreens for protection against UVA and UVB.
UVA and UVB are different wave lengths of ultraviolet light.
"For more than 30 years, consumers have been able to identify the level of UVB protection provided by sunscreens, using only sunburn protection factor or SPF values," von Eschenbach said in 2007. "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."
But nothing ever came of the regulations, even though they were approved and adopted as law, Blumenthal said. "They studied it for a decade," he said.
Both UVA and UVB are harmful. Besides premature wrinkling and aging of skin, the most serious risk is skin cancer. More than 800,000 cases are diagnosed in the U.S. every year, and the number is growing about 3 percent a year, according to the National Cancer Institute.
The NCI estimates 40 percent to 50 percent of fair-skinned people who live to 65 will develop at least one skin cancer.
Using sunscreen with a protective factor of 15 can reduce the risk of skin cancer by 78 percent -- if it is applied properly.
Among the rules is a new system to describe protection against UVB with numbers up to 50. Higher protection numbers afford only marginal benefits at higher cost, the FDA contends.
Potency against UVA would be presented on labels as a series of five stars representing low, medium, high and highest.
The FDA also produced a sample bottle, showing UVB and UVA protection factors displayed prominently, and the format of a new label listing ingredients, and instructions to reapply the product after swimming, and otherwise, every two hours.
"There really is no excuse for nonaction. There is no substantive reason given, nor possible, for why the rules have not been put into effect," Blumenthal said. "These rules should have been implemented months or years ago."
The FDA did not return calls for comment Tuesday.
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