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PARSOL 1789 5% MAXIMUM CONCENTRATION IN SUNSCREEN MONOGRAPH URGED

This article was originally published in The Tan Sheet

Executive Summary

PARSOL 1789 5% MAXIMUM CONCENTRATION IN SUNSCREEN MONOGRAPH URGED by Givaudan-Roure in a Nov. 16 letter to FDA. The letter from two Givaudan attorneys -- corporate counsel Eugene DeFelice and King & Spaulding attorney Edward Basile -- responds to an Oct. 27 letter from FDA in which the agency suggested that 3% might be an appropriate maximum concentration. The two attorneys contended that "a 5% maximum concentration would provide consumers with greater variety and flexibility in choosing sunscreen products." Givaudan-Roure is basing its 5% maximum concentration proposal on a recent amendment to the European Cosmetic Directive adopted by the European Community that supports the safety and efficacy of avobenzone at a 5% concentration. The company noted, however, that it "would accept a 3% maximum if FDA concludes that there is not enough evidence to support 5% maximum." To support the monograph status of Parsol 1789, Givaudan-Roure submitted to FDA additional studies, which the company says demonstrate the safety and efficacy of the ingredient. The company also included a summary of the data from Givaudan-Roure's 1989 NDA application for Parsol 1789 A (Parsol 1789 and Parsol MCX [ethylhexyl p-methoxcinnamate]). Although FDA has had access to the NDA data since 1989, Givaudan noted that the data had not been made public and, therefore, was "not . . . used by Givaudan-Roure to support the citizen's petition." The Givaudan submission cites the two already available avobenzone-containing NDAed sunscreens Schering-Plough's Shade UVAGuard and Herbert's Photoplex -- for providing U.S. marketing data to support monograph status for Parsol 1789. In addition, the company pointed to "over 100 commercial sunscreen products containing Parsol 1789" in varying concentrations that have been marketed and sold around the world since 1991. Foreign marketing data, the company asserted, also supports the safety and efficacy of the ingredient. FDA's Oct. 27 letter also addresses Givaudan-Roure's Sept. 24 objection to the possible delay of Parsol 1789's inclusion in the monograph pending an FDA workshop in the spring on UVA testing methods ("The Tan Sheet" Oct. 18, p. 9). Givaudan-Roure suggested that a delay would not "be in the best interests of the public." In addition, Givaudan-Roure again urged FDA to allow interim marketing of Parsol 1789 while monograph status of the ingredient is pending. Although the agency wants the company to propose a valid testing method for UVA screening efficacy, FDA acknowledged in the Oct. 27 letter that the testing procedure "need not be finalized before the agency determines whether or not avobenzone can be marketed on an interim basis." In response to FDA's reminder that any "water-resistant or very water-resistant claims" must be supported by data "demonstrating that the product maintains its UVA resistance" through relevant testing, Givaudan-Roure maintained that "no such requirement exists for manufacturers of sunscreen ingredients." Instead, the company suggested that the "manufacturer of sunscreen drug products should be required to support a waterproof or water- resistant claim using appropriate testing methodology." Givaudan-Roure also submitted comments on Oct. 20 to the tentative final monograph for sunscreen drug products in support of monograph status of Parsol 1789.
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