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This article was originally published in The Tan Sheet

Executive Summary

FDA REQUESTING "SCIENTIFIC DATA" TO SUPPORT SPF VALUES OVER 30 for sunscreen products in July 1 letters to the Nonprescription Drug Manufacturers Association and the Cosmetic, Toiletry and Fragrance Association. In the letters, FDA Monograph Review Staff Director William Gilbertson noted that the agency has "already received several comments objecting" to an SPF 30 upper limit proposed for OTC sunscreen products in the tentative final monograph published on May 12 ("The Tan Sheet" May 17, p. 10). "We expect the response to this proposal to be high, but we also expect that a majority of the comments will be anecdotal in nature," the letter states. "To resolve this issue, it will be necessary for the agency to have valid scientific reasons for establishing or not establishing a safe upper limit of SPF values." In addition to comments and "other data" on this issue, the agency said it is interested in seeing some "comparative data." FDA explained that it would like to see studies designed so that "the same subjects [are] tested with the same product or similar products formulated to have different SPF values." As an example, the agency suggested that a subject's MED (minimal erythema dose) on protected skin could be tested with sunscreens containing SPF values of 15, 30 and 45. FDA stated in the TFM that it felt that "SPF values above 30 are not necessary because the available data clearly indicate that a sunscreen drug product with an SPF of 30 assures adequate protection for the majority of consumers even under extreme conditions." The agency further concluded that the protection variability of SPF values above 30 is "so small as to be nonexistent." Gilbertson told NDMA and CTFA that the agency is "hoping that by advising your association of our thoughts on this matter early in the comment and new data periods, interested persons will have the opportunity to carry out appropriate testing and submit the data to the agency before the comment and new data periods close." FDA gave interested parties until Nov. 8 to submit comments on the TFM and one year to submit new data to support changes in the proposal. Citing consumer preference for high SPF values, Schering- Plough noted in a July 15 release that "in the four weeks ending May 15, three of the top ten sunscreen products in sales carried SPFs above 45." The Schering press release points out that "unless the FDA reverses its proposal, this could be one of the last summers such a high SPF will be available to consumers." Schering-Plough has not yet submitted formal comments to the agency on the proposal. Schering applauded the agency for its proposal to include a "sun alert" warning in product labeling that is aimed at educating consumers about the harmful effects of overexposure to the sun. However, Schering suggested that the proposed "sun alert" warning as well as the dangers of summertime exposure "seem contrary to the proposal to cap SPF at 30." In addition, Schering-Plough objected to the proposal in the TFM that limits a product's waterproof claims to "water resistant" or "very water resistant." Schering currently claims that its Coppertone Kids product "won't wash off for six full hours of outdoor water activity" based on clinical study results.

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