RECOMMENDED SUNSCREEN PRODUCT GUIDE IN LABELING IS "UNNECESSARY," CTFA
This article was originally published in The Tan Sheet
Executive Summary
RECOMMENDED SUNSCREEN PRODUCT GUIDE IN LABELING IS "UNNECESSARY," CTFA told FDA at an Oct. 21 "OTC feedback" meeting. Commenting on a proposal in the agency's tentative final monograph for OTC sunscreens that a Recommended Sunscreen Product Guide should appear on the principal display panel to suggest SPF values for five specific skin types based on their reactions to the sun ("The Tan Sheet" May 17, p. 16), Cosmetic, Toiletry and Fragrance Association President Edward Kavanaugh said the proposal is "quite unnecessary and actually pretty unworkable." Maintaining that the existing SPF system is adequate and "well understood" by consumers, CTFA Associate General Counsel James Skiles stated that "arguably, 25 years ago, the Recommended Sunscreen Product Guide might have been useful as people tried to figure out which sunscreen might have been useful to them. At this point, they know." Skiles also argued that the guide "provides way too much information, it cuts down on the other important information on the label, it detracts from it, and quite frankly we think it's information overload." He added that "there is absolutely no reason why a fair-skinned person, who knows that he or she needs [an SPF] 25 or 30, should be advised as to what a swarthy, olive- skinned person might need in the way of sunscreen protection." Required use of the product guide would create a "very unusual" situation "because it tells [consumers] what other products also do," Skiles said. Skiles pointed out that because sunscreens are typically sold in relatively small containers of four ounces or less and without outer cartons, "there just is not enough room to add the additional recommended product guide." Inclusion of the guide on labels, he stated, would make them virtually unreadable, and the guide "is just not that important." Skiles also maintained that with the growing pressure on industry to eliminate excess packaging based on environmental concerns, "there is absolutely no way you could do a package insert." FDA's OTC Monograph Review Staff Director William Gilbertson explained that the recommended product guide originated as an optional labeling feature in the agency's advanced notice of proposed rulemaking on sunscreens. After no comments were received on the guide, it was included in the TFM as a requirement. Gilbertson also noted, following CTFA's presentation, that "unfortunately, we didn't have these kinds of arguments when we were developing the tentative final [monograph] because no one, I guess because it was optional, commented on it." In response to a question from CTFA on whether the agency had data showing a need for the product guide, Gilbertson said that "we really don't give any real conclusions or basis . . . for making it a requirement [in the TFM] other than we think it would be useful information for consumers to have in purchasing the products."