PARSOL 1789 SAFETY/EFFICACY TO BE ADDRESSED IN AMENDMENT TO SUNSCREEN TFM

PARSOL 1789 SAFETY/EFFICACY TO BE ADDRESSED IN AMENDMENT TO SUNSCREEN TFM, FDA told Givaudan-Roure in an Aug. 19 letter. The letter responds to Givaudan-Roure's March 2 citizen petition requesting that FDA reopen the administrative record for OTC sunscreens to include broad-spectrum UVA filter Parsol 1789 (avobenzone) as an active ingredient in the sunscreen tentative final monograph. FDA stated that because the sunscreen TFM was published in May, the agency could not include a decision on Parsol 1789 in that document. FDA said it is considering the petition as a "request to amend" the TFM. The Givaudan-Roure petition was based primarily on data covering U.S. use of Parsol 1789 ("The Tan Sheet" March 8, p. 4). FDA said it "has determined that avobenzone can be included in the OTC rulemaking for sunscreens" due to the marketing of other avobenzone products in the U.S. One is Allergan Herbert's Photoplex combination sunscreen product containing avobenzone and padimate O, which has been sold under an NDA approved in September 1988. Another currently marketed product is Schering-Plough's Shade UVAGuard with avobenzone, octyl methoxycinnamate and oxybenzone. An NDA for Shade UVAGuard was approved by FDA in December 1992. The agency quoted a statement made by Givaudan-Roure in its petition as another reason that avobenzone is being considered in the OTC sunscreen rulemaking: more than 19 metric tons of avobenzone have been supplied for use in Photoplex since the product was launched, and over 5.5 mil. units of Photoplex have been sold in the U.S. to date. FDA underscored that it is "neither granting nor denying" Givaudan-Roure's request that it be allowed interim marketing of combination sunscreen products containing avobenzone pursuant to a tentative determination of safety and efficacy. However, "during the period while avobenzone is under agency review regarding its [safety and efficacy], neither the single ingredient nor the ingredient in combination with other sunscreen active ingredients may be marketed except under an approved NDA," the agency concluded. Based on FDA's compliance policy for marketing OTC combination products, FDA explained, sunscreen combinations not reviewed by an OTC drug review panel "may be marketed only after" a notice is published in the Federal Register that the "combination has been tentatively determined to be" safe and effective and that "the OTC marketing of such products will be permitted under specified conditions." The agency also pointed out that "before marketing may begin," the comment period for a potential amendment to the TFM on avobenzone "must have ended and another Federal Register notice must have been published setting forth the agency's determination concerning interim marketing prior to publication of the final rule." FDA said it is also "deferring action" on Givaudan-Roure's other petition request -- that avobenzone-containing broad spectrum combination sunscreen products be permitted on the market in a "full range of SPF values" -- pending review of the safety and effectiveness data submitted by the company in the petition. "At a later date, our tentative conclusions and any interim marketing status will be stated in the Federal Register," the agency told the firm. Givaudan-Roure Marketing-Cosmetics Ingredients Group Director Gilbert Pittet commented in a release that the company views the FDA letter as a "very good start." He declared that public health concerns of UVA exposure "make it imperative that FDA act quickly to review Givaudan-Roure's request to permit interim marketing of these products," adding that "FDA needs to provide consumers with the practical tools, at different SPF values, to protect themselves from the recognized dangers of UVA." FDA has not yet officially responded to an October 1990 petition submitted by Givaudan-Roure, based primarily on foreign use data, that seeks to add avobenzone to the sunscreen TFM as a Category I (safe and effective) ingredient. The agency, however, is currently in the process of formulating a broad policy on whether overseas marketing data will be accepted in petitions for monograph status of OTC ingredients ("The Tan Sheet" May 24, p. 1).