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UVA TESTING METHODOLOGY SHOULD BE FDA "PRIORITY," SEN. LIEBERMAN

This article was originally published in The Tan Sheet

Executive Summary

UVA TESTING METHODOLOGY SHOULD BE FDA "PRIORITY," SEN. LIEBERMAN declared in an Oct. 21 letter to FDA Commissioner David Kessler. Sen. Joseph Lieberman (D-Conn.) accused FDA of proposing "to permit UVA protection claims on the label of sunscreens based on a test that does not yet exist" in its sunscreen tentative final monograph. Development of "this critical test method should be a priority," he asserted. "Until the FDA develops a meaningful testing procedure for UVA efficacy," Lieberman argued, "consumers will not have adequate information on the benefits and limitations of sunscreen products." The Connecticut senator asked Kessler what resources FDA planned to devote "within the next year to developing such a test method." FDA announced plans to hold a workshop on UVA testing methods next spring ("The Tan Sheet" Oct. 18, p. 9). Lieberman also urged the agency to promulgate a final sunscreen monograph as soon as possible to ensure that UVA claims are made only by products that have an absorption spectrum extending to 360 mm or above in the UVA range, as specified by the TFM ("The Tan Sheet" May 17, pp. 10-19). Until "the monograph becomes final, however, sunscreens containing ingredients that protect against only shorter-wavelength UVA can continue to make UVA claims," he concluded. In general, Lieberman told FDA to "move as quickly as possible to clarify UVA protection claims and to facilitate the introduction of products that protect effectively against UVA protection." Lieberman noted that "experts have indicated that at least one ingredient, [Givaudan-Roure's] Parsol 1789, provides good UVA protection." He recommended that the agency "modify the monograph to include any ingredient FDA believes to be effective in protecting against UVA and should otherwise facilitate the availability of sunscreen products containing ingredients that protect against UVA." Givaudan has been submitting studies to the agency to support monograph status for Parsol 1789 ("The Tan Sheet" Nov. 22, p. 19). Lieberman held a Senate hearing on the adequacy of sun protection from sunscreens and sunglasses in June 1992. He wrote to FDA not long after the hearing to express "concerns regarding the inadequacy of existing labeling rules." In the Oct. 21 letter, Lieberman explained that he was writing the agency again because "the tentative final monograph leaves many of my concerns unaddressed." One concern, Lieberman explained, is that "FDA staff have informed my staff that it will be three years at a minimum before the FDA publishes a final monograph." The agency's "inability to issue a final enforceable regulation within a reasonable time frame is nothing less than an abdication of its responsibility to protect the public health," he asserted. Lieberman also maintained that the TFM's "labeling approach inadvertently misleads consumers regarding immune system risks." Although "witnesses testified at our hearing that UV radiation may harm the immune system," Lieberman stated, "I am troubled that the tentative final monograph contains not a single reference to this concern." Instead, the senator continued, the TFM requires sunscreen labels to contain the warning: "SUN ALERT: The sun causes skin damage. Regular use of sunscreens over the years may reduce the chance of skin damage, some types of skin cancer and other harmful effects due to the sun." The first sentence of the sun alert "is a very weak warning," Lieberman asserted, noting that "skin damage" could "simply mean wrinkles." The Connecticut senator also suggested that consumers could infer from the statement "that he or she is well protected from any harmful effects from the sun, including immune system damage. Hence, consumers may ultimately expose themselves to greater levels of UV than they would if they were fully informed of potential UV risks." Regarding SPF labeling requirements proposed in the TFM, Lieberman complained that the monograph "does not require that labels explain the basis for SPF numbers." He also expressed concern that the "Recommended Sunscreen Product Guide," which would advise individuals to use sunscreens with certain SPF levels based on their skin types, "steers many consumers toward low SPF products." Lieberman pointed out that "experts" testifying at the June 1992 hearing said that "they generally recommended the use of products rated at SPF 15 or above, but indicated that for those individuals who wanted to acquire a tan, a lower SPF product was better than nothing." Following this reasoning, Lieberman maintained that "it is not clear whether the recommendations in the product guide are for consumers who want a tan or consumers who want to minimize their health risks, but it seems to be directed at the former." "In any event," the senator continued, "the guide fails to indicate that consumers who want full protection should use an SPF 15 or above." Unless the guide is clarified, Lieberman warned that "consumers will not be able to make informed choices about tanning and reducing their health risks." The Cosmetic, Toiletry and Fragrance Association also objected to the Recommended Sunscreen Product Guide at a recent "OTC feedback" meeting, stating that it is "unnecessary" and "pretty unworkable" ("The Tan Sheet" Oct. 25, p. 20). The Recommended Sunscreen Product Guide, Lieberman said, "gives no recommendation to consumers who never burn, yet sunscreens may benefit these individuals" due to the potential reduction of skin cancer risk and immune system effects. "Sunscreen labels should reflect the benefits sunscreens confer to individuals who never burn," he advised. Concluding his letter to Kessler, Lieberman noted that "it seems to me that a more accurate approach would: more clearly state the risks associated with sun exposure; convey the uncertainty regarding sunscreens" protection against UVA rays and immune system effects; and recommend SPF values more consistent with the advice of experts." These changes, he said, "would better enable consumers to make informed choices about their sun exposure and sunscreen use." FDA has not yet responded to Lieberman's letter.
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