Sunscreen/Insect Repellant Combinations Should Be Monographed – CTFA
This article was originally published in The Rose Sheet
Executive Summary
FDA should include insect repellent/sunscreen combination products in the over-the-counter sunscreen monograph, the Cosmetic, Toiletry and Fragrance Association says
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FDA should include insect repellent/sunscreen combination products in the over-the-counter sunscreen monograph, the Cosmetic, Toiletry and Fragrance Association says. Combination products that meet Environmental Protection Agency standards on insect repellents should be allowed on the market provided they "otherwise comply' with FDA's sunscreen monograph, CTFA suggests in comments submitted to the agency May 23. FDA announced that it was considering amending the monograph to include insect repellents with sunscreen ingredients earlier this year, publishing a request for information in the Feb. 22 Federal Register (1 (Also see "FDA Mulls Adding Insect Repellent Combinations To Sunscreen Monograph" - HBW Insight, 26 Feb, 2007.), p. 4). Insect repellents with sunscreen ingredients are not currently included in the monograph. Instead, FDA has exercised enforcement discretion to permit the marketing of these products so long as they are registered with EPA and the sunscreen ingredients included in the FDA rulemaking. Existing FDA and EPA regulations and testing requirements are "sufficient" to ensure the safe use of combination products, CTFA asserts. CTFA recommends that the monograph be amended to include a new subpart for combination repellent/sunscreen products. That subpart should recognize the agencies' joint jurisdiction. To avoid labeling conflicts and minimize the burden on companies striving to comply with two systems, CTFA maintains that exemptions from the OTC Drug Facts Labeling rule "are not only feasible, but appropriate." No radical new testing requirements are needed for the combination products, CTFA says. For example, the group says the stated SPF value of a combination product should reflect any "purported effect of the insect repellent active ingredient in the SPF testing that is conducted in accordance with FDA's OTC sunscreen monograph requirements." FDA said in its February request for information that inclusion of the combination category in the monograph could lead to some products being removed from the market or subject to filing a new drug application, CTFA General Counsel Elizabeth H. Anderson said such occurrences would be rare. - Melina Vissat ([email protected]) |