EPA/FDA Request Comments on Regulation of Insect Repellent-Sunscreen Combination Products
The Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) have each issued notices requesting comments to determine how insect repellent-sunscreen combination products should be regulated.
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Comments must be submitted by May 23, 2007.
EPA and FDA are considering, among other things, issues such as labeling, product performance, applicable safety standards, and marketing for all currently (and any future) registered insect repellent-sunscreen combination products. According to the agencies, the decision on what regulations, if any, to propose will be based, in part, on information and comments submitted in response to these notices.
(EPA regulates the insect repellent component and FDA regulates the sunscreen component of these products.)
EPA Requests Information for "Reregistration" of Combination Products
EPA explains that it is responsible for reevaluating previously registered pesticide products through a program called "reregistration." In order to reregister a pesticide, EPA determines whether the product meets current scientific and statutory standards.
EPA states that due to concerns about the potential conflict in labeling for the insect repellent and the sunscreen portions of the product, EPA postponed a reregistration eligibility decision (RED) on whether to reregister the combination N,N-diethyl-meta-toluamide (DEET)-sunscreen products until additional information could be obtained. EPA is requesting information in order to complete the reregistration review which was described in the RED document for the insect repellent DEET.
FDA Requests Information on Monograph for OTC Sunscreen Products
According to FDA, it is considering amending its monograph for over-the-counter (OTC) sunscreen drug products in 21 CFR Part 352 (the regulation that establishes conditions under which these drug products are generally recognized as safe and effective and not misbranded) to add conditions for marketing insect repellent-sunscreen drug products.
(According to EPA and FDA, there are currently approximately 20 combination insect repellent-sunscreen products available for consumers. Each of these products contains an insect repellent component (DEET, oil of citronella or IR3535) and a sunscreen component.)
| Richard Gebken (EPA) | (703) 305-6701 |
| Matthew Holman (FDA) | (301) 796-2090 |
EPA notice (D/N EPA-HQ-OPP-2007-0087; FRL-8114-6, FR Pub 02/22/07) available at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-3008.pdf
FDA notice (D/N 2006N-0479, FR Pub 02/22/07) available at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-2890.pdf