PARSOL 1789 MONOGRAPH STATUS AS BOTH SINGLE AND COMBINATION INGREDIENT

PARSOL 1789 MONOGRAPH STATUS AS BOTH SINGLE AND COMBINATION INGREDIENT is supported by data submitted to FDA and by U.S. marketing experience, Givaudan-Roure asserts in a Nov. 16 letter to FDA from corporate attorney Eugene DeFelice and outside counsel Edward Basile from the Washington, D.C. firm of King & Spalding. Givaudan-Roure seeks to include Parsol 1789 (avobenzone) in the monograph, the letter says, "as both a single ingredient and a combination ingredient for use with any other Category I ingredient . . . to provide product flexibility." Listing Parsol 1789 as both a single and combination ingredient corresponds with the "other 20 ingredients . . . currently listed in the monograph," Givaudan-Roure stated in the letter. The company does not expect significant demand for products that contain only the UVA sunscreen ingredient, the letter comments, but maintains that a dual listing is "appropriate . . . in the event the marketing of current Category I ingredients changes substantially, and . . . products are sold as single ingredients." In response to an Oct. 27 letter from FDA requesting data to support listing Parsol 1789 in the monograph for both single- ingredient and combination use, Givaudan-Roure submitted additional studies, which, the company said demon- strata "the safety and efficacy of Parsol 1789." The data include human clinical studies, animal model studies, dermatological studies, skin penetration studies on animal models and toxicological studies. Givaudan has submitted "significant and voluminous data," the Nov. 16 letter states. In conjunction with "the extensive marketing experience of Parsol 1789 in the U.S." from the two NDAed avobenzone-containing sunscreens (Schering-Plough's shade UVAGuard and Herbert Labs' Photoplex, Givaudan maintained that the data "demonstrate that Parsol 1789 provides full spectrum UVA protection." The Givaudan attorneys added that the data "provide more than an adequate basis for the extrapolation of the safety and efficacy of Parsol 1789 to combinations with other Category I ingredients." Givaudan-Roure also maintained that, if Parsol 1789 were granted monograph status, FDA's "regulations and guidelines governing the combination of Category I ingredients" would allow avobenzone to be "combined with any other Category I sunscreen ingredient without providing data to demonstrate the safety and effectiveness of each combination possibility." FDA had asked Givaudan-Roure to provide "alternate" label suggestions "for indications, warnings, directions for use, and other pertinent information" for OTC sunscreen products. Specifically, FDA suggested that the company submit labeling for review to alert consumers "to the disparity between the high level of sunburn protection provided by the high SPF value and the relatively lower level of UVA protection offered by a product containing avobenzone." The agency indicates in the letter that it will use the approved NDA labeling as a guide for labeling products containing Parsol 1789. In an earlier "partial response" to FDA's letter dated Nov. 1, Basile offered a clarification on behalf of Givaudan-Roure that "no extra labeling is . . . necessary" to alert consumers using high SPF value sunscreen to the lower level of UVA protection provided by avobenzone. "No sunscreen ingredient will completely block all UVA spectrum radiation," Basile contended, "just as no UVB sunscreen ingredient will provide protection from all UVB radiation." Instead, Givaudan-Roure urged FDA to consider a mandatory label that warns consumers of the "recognized dangers of UVA" for high SPF sunscreens that do not contain avobenzone. The company said it is concerned with the "danger posed to consumers who are unaware that traditional sunscreens do not protect them from exposure to UVA radiation." The Givaudan attorneys also claimed in the Nov. 16 letter that Parsol 1789 is "the only full spectrum UVA sunscreen ingredient." Therefore, the company asserted, a claim of "full spectrum protection should only be permitted for products containing Parsol 1789."