FDA CONSIDERS UVA SUNSCREEN PROTECTION CLAIMS "UNACCEPTABLE"

FDA CONSIDERS UVA SUNSCREEN PROTECTION CLAIMS "UNACCEPTABLE" and "any such product that displays UVA protection claims may be subject to regulatory action," OTC Drug Evaluation Division Director William Gilbertson informed several sun-screen manufacturers and researchers in Feb. 22 FDA "feedback" letters. Claims such as "broad spectrum" and "UVA/UVB sunblock" are "considered unsubstantiated because there are no generally recognized testing procedures for determining UVA protection," Gilbertson said. * FDA believes that "protection against UVA radiation is becoming much more important than previously realized" and "may be as important to a consumer's well-being as protection against UVB radiation." Once an acceptable testing method is developed, consumers will benefit from labeling "that clearly indicates" if a product provides UVA protection, the letter said. The agency plans to propose that a Category I sunscreen ingredient be required to have an absorption spectrum extending to 360 nanometers or above in order to make UVA protection claims. Such ingredients may include dioxybenzone, sulisobenzone, red petrolatum, titanium dioxide, octyl methoxycinnamate and octocrylene. Sunscreen ingredients that had spectra extending only into the lower UVA range, such as oxybenzone, may not provide adequate protection, the agency said. FDA said that it is aware that UVA radiation contributes to both acute and chronic skin damage such as photoaging, erythema, melanogenesis, carcinogenesis and drug-induced photosensitivity. In addition, the agency is concerned that UVA radiation may penetrate the skin "more efficiently" than UVB and that the increasing use of higher sun protection factor (SPF) sunscreens may result in consumers spending longer hours in the sun and increasing their exposure to UVA rays. The feedback letter was sent to Schering-Plough, Westwood Pharmaceuticals, Mary Kay Cosmetics, UCLA dermatology professor Nicholas Lowe, M.D., and Harvard Medical School dermatology professor Madhu Pathak, PhD, in response to comments they submitted on the issue in 1987 and 1988. In addition, FDA issued a second feedback letter concerning potential testing procedures for UVA sunscreens. Copies of both letters were sent to the Cosmetic, Toiletry and Fragrance Association and the Nonprescription Drug Manufacturers Association. Sunscreens currently making broad spectrum claims include Schering-Plough's Super Shade SPF 44 Broad Spectrum Sunblock; Hawaiian Tropic Sunsitive SPF 30 (Hawaiian Tropic); Westwood's PreSun SPF 30; Johnson & Johnson's Purpose, Piz Buin and Sundown; the Mary Kay sunscreen line; and Herbert Labs' Photoplex. FDA cited Schering-Plough's Shade Sunblock as an example of a broad spectrum sunscreen with "misleading and confusing" labeling. Shade includes a UVA protection percent number, or APP. The label reads "APP 81%" and "Blocks 81% of UVA Burning Rays." Consumers may assume that 81% of UVA radiation will be blocked by the product, FDA noted. In fact, protection is limited to 81% of the UVA radiation between 320 and 340 nm (UVA's "burning" radiation). Such labeling might mislead consumers as to the degree of protection they are receiving and put them at risk for "serious damage to the skin," FDA said. "Although we expect to propose additional UVA protection indications in the tentative final monograph and to ask for public comment, at this time the agency considers any new labeling relating to UVA indications or any numerical factors designed to indicate UVA protection...to be unsubstantiated and unacceptable," the letter said. The agency does not believe a separate call for data on UVA is necessary; instead, firms may submit data after the publication of the TFM and, if necessary, an amendment will be published. * In the second feedback letter, FDA said that it does not have enough information to propose a testing method for determining UVA protection and will request comments and data regarding an appropriate method in the upcoming TFM on OTC sunscreens. Any proposed method should include the use of a control sunscreen preparation that absorbs UVA radiation and can be used to assure the reliability of the testing procedure and equipment, the letter said. The method does not necessarily have to produce meaningful phototoxic protection factor (PPF) or UVA protection factor, FDA said, but should demonstrate that an ingredient either does or does not protect UVA radiation. If a proposed method does obtain a PPF, FDA will consider the factor for inclusion in sunscreen labeling.