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Executive Summary

FDA OTC SUNSCREEN MONOGRAPH SHOULD ALLOW ANTI-AGING CLAIMS for sunscreens and products such as moisturizers that contain a sunscreen, Bristol-Myers subsidiary Westwood Pharmaceuticals suggested in a June 28 letter to the agency. According to Westwood, "phrases such as 'anti-aging' would be consistent with the current [proposed] monograph, so long as the product contains only Category I (safe and effective) sunscreen ingredients, and discusses its use in the prevention or alleviation of the visible effects of exposure to UV rays which may cause premature aging." Westood's letter followed the firm's receipt of a June 16 regulatory letter citing its Anti-Aging Moisturizing Sun-Screening Lotion for making drug claims. FDA further charged Westwood with failing to have "adequate directions for use in the treatment for which the article is represented or suggested." The lotion is promoted as a moisturizer to help prevent premature aging of the skin. FDA requested that the firm "take prompt action to correct these violations" or face possible seizures or injunctions. FDA previously stated its position on anti-aging claims for sunscreen-containing products in a September letter to Estee Lauder; the agency maintained then that the presence of sunscreen ingredients in a cosmetic does not justify use of claims such as anti-aging and anti-wrinkling. The proposed monograph statement that regular use of a sunscreen may help reduce the chance of premature aging of the skin "applies only to sunscreen products complying in every respect with the labeling requirements proposed for this product category," FDA said then. Westwood augmented its request to allow anti-aging claims with a concurrent suggestion that FDA "explicitly" allow and encourage labeling that recommends daily use of sunscreen products. The company argued that current data on photoaging show that "exposure to UV light has an additive effect, suggesting that long-term exposure to low-dose radiation is as damaging as short-term exposure to higher intensity UV light." In support, Westwood cited new studies presented at a National Institutes of Health (NIH) Consensus Conference which led to the consensus panel's recommendation of "regular, daily use of sunscreens to protect against photoaging effects" ("The Pink Sheet" May 15, p. 16). In addition, Westwood referred to studies by "eminent dermatologists and experts" who "recognize the proven benefits of a sunscreen product in a suitable base, such as a moisturizer, for daily use in the prevention of photoaging." Westwood noted that the NIH Panel also recommended that "combination sunscreens that are effective against UVB and UVA are preferable." As a result, the company "urges the inclusion of a requirement in the final monograph that sunscreens labeled for their anti-photoaging or anti-skin cancer properties contain UVA protection or prominently disclose the absence of such protection." The firm said that sunscreens with high sun protection factors (SPF) could be "worse than no protection at all" if they only protect against UVB rays since, Westwood maintains, consumers would be deluded in thinking they were fully protected. A "uniform UVA protection measuring and labeling system" also should be required, Westwood said. Current SPF designations refer to the degree of erythema produced by exposure to UVB rays, the company noted. Therefore, a separate test methodology is needed to measure UVA protection. Westwood suggested using "a specially modified, concentrated beam, xenon arc solar simulator . . . to determine a sunscreen UVA protection factor," a method published in The Journal of the American Academy of Dermatology in May.

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