Dual Label Meets Repellent/Sunscreen Requirements By FDA, EPA – Chattem
This article was originally published in The Tan Sheet
Executive Summary
A single label for insect repellent sunscreen products could meet the requirements of both FDA and the Environmental Protection Agency without confusing consumers, Chattem says in comments to FDA
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A single label for insect repellent sunscreen products could meet the requirements of both FDA and the Environmental Protection Agency without confusing consumers, Chattem says in comments to FDA. "A single, integrated label will provide the consumer with important information in a clear, simple and effective manner," the firm says. Chattem submitted comments in response to FDA's Feb. 22 Federal Register notice soliciting feedback on whether to include insect repellent/sunscreen products in the sunscreen monograph and whether doing so would create labeling conflicts with EPA requirements (1 (Also see "FDA Mulls Adding Insect Repellent Combinations To Sunscreen Monograph" - Pink Sheet, 26 Feb, 2007.), p. 3). Repellent ingredients were not included in a long-awaited proposed rule to amend the sunscreen final monograph FDA published Aug. 23 (2 (Also see "Sunscreen Proposed Rule May Create UVA Protection Marketing Opportunity" - Pink Sheet, 27 Aug, 2007.), p. 3). FDA says although repellant ingredients are not included in the sunscreen monograph, it has traditionally used its "enforcement discretion" to allow marketing of combination products as long as those ingredients were approved by EPA. However, if FDA assumes authority over these products, any combination "containing an unsuitable inactive ingredient or an active drug ingredient that is not included in the final monograph" will be considered a new drug and will require a new drug application, even if it is registered with the EPA, according to the agency's February notice. In comments it submitted in May, Chattem maintains that in order to satisfy EPA and FDA requirements, labeling for combination products could "utilize both text and pictorials." Packaging could contain a Drug Facts box for FDA-required labeling, including directions, warnings and storage, and EPA-required information, such as disposal and first aid, could be placed outside the box, according to the firm. Chattem says its Bullfrog Mosquito Coast product contains insect repellent IR3535, as well as sunscreen ingredients on a "clear and easily understood" label. Chattem says the label instructs users to "apply liberally and evenly over dry-exposed skin," as well as to reapply after eight hours for protection from mosquitoes. For sun protection, the label instructs to reapply after toweling off or as often as needed, but not to exceed seven applications per day for adults and three for children, according to the firm. Chattem says Mosquito Coast also contains a warning to avoid application directly to sensitive body parts. Its labeling reads: "Do not spray directly on face. Spray on palm of hand and apply to face." The Chattanooga, Tenn.-based firm, which says it has received no complaints about the product's label from consumers, also addressed other FDA concerns, including specific details on how ingredients in the products should be listed. The firm says to comply with FDA requirements, insect repellent/sunscreen product labels can "list the inert or inactive ingredients in alphabetical order under the heading 'inactive ingredients,'" and continue to list "Inert/Other Ingredients" by percent on the Principal Display Panel. Additionally, Chattem says labels can clearly state products contain pesticides using "14-font size immediately under the brand name." Chattem also addressed FDA's concern about conflicts between EPA and FDA requirements, noting "the current EPA-FDA joint regulatory authority over the products' manufacture ensures that safe and effective insect repellent-sunscreen products are on the market." About 20 combination products are marketed in the U.S. The products typically contain one of three insect repellent ingredients-IR3535, DEET or oil of citronella - as well as one sunscreen ingredient. The Cosmetic, Toiletry and Fragrance Association sent comments to FDA encouraging including combination products in the monograph (3 (Also see "Sunscreen/Insect Repellent Combinations Should Be Monographed – CTFA" - Pink Sheet, 28 May, 2007.), p. 7). In its comments, Avon, which markets Skin So Soft Bug Guard, urged FDA to create a monograph subpart for combination products and to exempt the products from certain format requirements for OTC labeling (4 (Also see "Sunscreen/Repellent Comments Stress Aligning FDA, EPA Label Regs" - Pink Sheet, 2 Jul, 2007.), p. 5). - Eileen Francis ([email protected]) |