The U.S. Food and Drug Administration recently announced that it will extend until Dec. 31, 2002, its requirement for sunscreen manufacturers to comply with many of the regulations set forth in its 1999 sunscreen monograph. The deadline extension will allow additional time for FDA to complete a more comprehensive set of regulations to include both ultraviolet-A (UVA) and ultraviolet-B (UVB) radiation protection, as well as to further examine the use of a cap on SPF claims.
Sunscreens are classified by their SPF, which is the products ability to screen or block out predominantly UVB radiation from the sun. UVB rays have been known for many years to be the primary cause of sunburn and skin cancer.
UVA radiation has now also been linked to skin cancer and premature aging. The longer wavelengths of UVA radiation allow it to penetrate deeper into the skin and cause damage to elastic fibers, even without generating a visible sunburn.
Martin Weinstock, M.D., Ph.D., professor of dermatology at Brown University and chief of dermatology at the VA Medical Center, Providence, R.I., found that even if a sunscreen does provide substantial protection against UVA rays, "there is actually very little information conferred by the statement on the bottle that this sunscreen protects against UVA." Guidelines for both testing and labeling of UVA protection were not included in the 1999 monograph.
The degree of carcinogenicity of UVA, as well as that of UVB and UVC radiation, is the subject of an upcoming National Toxicology Program report. William Jameson, Ph.D., of the National Institute of Environmental Health Sciences, Research Triangle Park, N.C., said that this compilation of research findings is scheduled for release later this month. Solar UV radiation and exposure to sunlamps and sunbeds are already listed as known human carcinogens in the National Toxicology Programs 9th Report on Carcinogens, released in May.
UV Radiation and Cancer
Recent studies suggest that UVB and UVA may work synergistically to cause skin cancer, said Darrell Rigel, M.D., clinical professor of dermatology at the New York University School of Medicine and immediate past president of the American Academy of Dermatology. So why is information about only UVB protection consistently included on the sunscreen label? There are two issues at hand: testing and labeling.
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"The only way to test how effectively a sunscreen blocks UVA," said Rigel, "is to change something from the natural environment . . . and all of these methods have advantages and disadvantages."
Even after standardization of UVA testing is achieved, questions of labeling remain. SPF predominantly describes UVB protection to the consumer, but there is now no standardized wording to describe UVA protection. As a result, the FDA is exploring the use of the labeling term "broad spectrum" to represent protection against both UVA and UVB exposure.
The American Academy of Dermatology recommends that only sunscreens that pass both in vitro and in vivo UVA testing should be labeled as broad spectrum, based on a pass/fail threshold. Because studies have found that the term SPF is relatively well understood by consumers and there could be confusion if two numbers are used on a label, the academy recommends that sunscreen labels include an SPF number to represent UVB protection, as well as a statement about whether a product has broad spectrum/UVA coverage.
A Cap on Sunscreen?
In addition to the omission of UVA protection regulations, the FDAs ban on SPF claims greater than 30based on study findings that the use of higher SPF sunscreens can lead to consumer overconfidence and, thus, increased sun exposurehas raised objections from the Cosmetic, Toiletry, and Fragrance Association and the American Academy of Dermatology. According to the 1999 regulations, a sunscreen must be labeled with an SPF number up to 30 but, if the SPF factor were higher than 30, it would simply be labeled as "30+."
The CTFA opposes the SPF 30 cap on constitutional grounds, stating that "Such a prohibition on truthful claims would be an unconstitutional restriction on commercial free speech. . . ." It suggests instead that high-SPF products be accompanied by a label stating that such products are "not intended to extend the time spent in the sun."
The AAD takes a different approach, expressing concern that a cap on SPF may be detrimental to the public because it could inhibit research on sun protection.
According to Weinstock, the cap on SPF labeling is not a major issue for the public as a whole. "I think that if the general public uses SPF 30 or greater, thats sufficient." As Weinstock explained, SPF is a reciprocal function: SPF 15 lets in 1/15 of the burning rays; SPF 30 lets in 1/30; and SPF 50 lets in 1/50. Therefore, the difference between SPF 30 and SPF 50 is only a difference of 97% effectiveness versus 98% effectiveness. "That little bit may be important to some people who have particular sensitivity," said Weinstock. "But, to the general public, it really is not that critical."
As UVA and UVB labels are debated, another issue looms in the field of sun protection. Testing of sunscreen products now measures sunburns, but the absolute connection between sunburn and skin cancer is still not known. In the meantime, dermatologists agree that in addition to information about UVA and UVB protection, labels should include directions on how often to reapply sunscreen, how resistant it is to water, and how thickly to apply it. Dermatologists also stress that sunscreen is only part of an overall sun protection regimen that also includes wearing protective clothing and avoiding the midday sun.
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