Executive Summary

OTC SUNSCREEN TFM WILL NOT ADDRESS UVA I AND UVA II subsegments of the UVA spectrum, OTC Drug Evaluation Director William Gilbertson said at a May 3 OTC feedback meeting with Herbert Labs. However, "UVA will be addressed in the [tentative final monograph]...albeit in a terse way," Gilbertson said, "but not to the extent and scope" that industry may expect. Gilbertson noted, for example, that data recently presented to FDA by Schering-Plough distinguishing the damaging effects of UVA I (340-400 nanometer) and UVA II (320-340 nanometer) wavelengths will not be discussed in the TFM "at this time." Herbert Labs, the only firm to have an approved NDA for a UVA/UVB sunscreen protector (Photoplex), attended the meeting to discuss the status of the TFM proceedings. The firm said it recently sent several letters to the agency concerning broad spectrum claims that are appearing on labeling and promotional materials for various OTC sunscreen products. Such claims "we though were perhaps misleading and represent a potential...health risk to the public," the company said. In addition, the Allergan business has been sending to the agency, on a weekly basis since Dec. 1, promotional and labeling samples from various products containing broad spectrum protection claims. The firm maintains that the promotional materials are not in line with appropriate labeling as outlined in FDA's Feb. 22 "feedback letter" to several sunscreen marketers and researchers. The FDA letter objected to broad spectrum claims on the basis that a testing standard has not yet been adopted to support claims for both UVA and UVB protection. Gilbertson suggested that FDA most likely will amend the TFM, following its anticipated release at year-end, to include updated information such as Schering-Plough's UVA I and UVA II data. He predicted it will take "two years probably...before we have something in a more definitive way which we could all respond to." Commenting on the status of the document, the OTC director said: "The TFM is well along on its way to what we call the final draft stage," now over 500 pages. "It is too cumbersome at this time to deal with issues like" UVA I and UVA II, he said, "but those things will be addressed when the record reopens upon publication of the TFM." Herbert Labs asked Gilbertson if firms are permitted to go against FDA's recommendations in the feedback letter and continue to make broad spectrum claims. The FDAer responded that the OTC review is a review of marketing conditions "up to 1975," and "anything new and above and beyond what has already traditionally been in the marketplace [up to 1975] would...not be allowed." He also remarked, "it is unfortunate that we're going backwards...to what the market had before, and conducting this review so late." Herbert Labs President Thomas Bender expressed concern about industry's response to the FDA feedback letter: "It would appear to me that some companies that would have received the letter may be taking advantage of the situation and not changing at all." Reportedly, the company is most concerned with the labeling and promotional advertising of Schering-Plough, which markets the Shade sunblock line with a "UVA protection percent number," and Hawaiian Tropics' Sunsitive sunscreen products.