OTC Sunscreen Drug Products: Towards Greater Protection

Abstract

It is important for the public to know that sunscreens are not a panacea for the adverse effects of solar radiation and that they are not a substitute for avoidance of the sun. Along with the many benefits attributed to sunscreen products, there is also the risk that these products create a false sense of security among consumers. Consumers have also been susceptible to being misled about the promoted uses and relative value of sunscreen products. Finally, consumers have not always been well-informed about how and when such products should be applied. In regulating sunscreen products, the Food & Drug Association (FDA) has taken up many of these concerns as it seeks to ensure that such products are safe and effective and not misbranded. Relief and guidance from the FDA have come in the form of the Tentative Final Monograph (“TFMâ€) for Over-the-Counter (“OTCâ€) Sunscreen Drug Products, a comprehensive regulation of OTC sunscreen drug products, which, in its final form, will be codified in 21 C.F.R. §352. This paper first seeks, in background, to discuss the role of the TFM system in regulating sunscreen products. It will then both examine two prominent controversies, namely the problem of UVA protection and the proposed cap on SPF values, and then assess the related deficiencies of the current labeling scheme under the TFM for OTC Sunscreen Drug Products. Finally, the paper will discuss the barriers to more comprehensive protection in sunscreen products.