Skin Protectant Chafing Indications Should Be Included In Final Rule - CTFA
This article was originally published in The Rose Sheet
Executive Summary
The OTC Skin Protectant Drug Products Final Monograph should include indications for chafing based on conclusions made by FDA in the tentative final monograph, according to the Cosmetic, Toiletry and Fragrance Association
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The OTC Skin Protectant Drug Products Final Monograph should include indications for chafing based on conclusions made by FDA in the tentative final monograph, according to the Cosmetic, Toiletry and Fragrance Association. "Consumers have in the course of the 20 years of the tentative final monograph, come to understand the different between 'chafing' and 'chapping,'" and medical experts also have drawn a distinction between the two conditions, CTFA states in a July 7 petition to the agency. In the TFM published in 1983, FDA proposed the indication "helps prevent and temporarily protects chafed, chapped, cracked or windburned skin and lips" for certain skin protectant products. Indications published in the June 4 1 final rule were modified, eliminating the chafing and "helps prevent" indications (2 (Also see "Skin Protectant Final Rule Allows Cross-Monograph Ingredient Combinations" - HBW Insight, 9 Jun, 2003.), p. 3). CTFA also requested FDA include the indication "helps prevent" in the final rule, noting manufacturers have labeled products with "helps prevent" for more than 20 years. "Skin protectant products are selected frequently for their preventative as well as protective benefits," CTFA asserts. "'Helps prevent' in the context of dry lips, e.g., carries a different meaning to the consumer than 'temporarily protects' and 'helps relieve.'" While FDA explained its decision to eliminate "helps prevent" and "chafed" for certain glycerin concentrations in the preamble to the rule, the agency deleted the indications for all monograph ingredients without adequately explaining why, CTFA says. "Whether this was deliberate or an oversight, we believe the record and the long history of use of these claims justifies reconsideration and reinstatement of these important indications," the association concludes. CTFA also requests FDA stay the effective date of the final rule until the issue has been resolved. The final rule is slated to become effective June 4, 2004. The association submitted a petition to FDA regarding 24-hour protection claims in the antiperspirant final monograph as well (see 3 (Also see "Antiperspirant Duration Claims Limit Revision Sought By CTFA" - HBW Insight, 21 Jul, 2003.) ). |