FDA Issues Final Guidance Clarifying FDA and EPA Jurisdiction over Mosquito-Related Products

Today, the U.S. Food and Drug Administration (FDA) finalized guidance to provide information on FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products, including those produced through the use of biotechnology.

The final Guidance for Industry #236 – Clarification of FDA and EPA Jurisdiction over Mosquito-Related Products – clarifies that mosquito-related products intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes for population control purposes, and that are not intended to cure, mitigate, treat, or prevent a disease are not “drugs” under the Federal Food, Drug, & Cosmetic Act, and will be regulated by the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act. The FDA will continue to have jurisdiction over mosquito-related products that are intended to prevent, treat, mitigate, or cure a disease (including by an intent to reduce the level, replication, or transmissibility of a pathogen in mosquitoes).

Given the public health implications of mosquito control, the FDA developed this guidance in coordination with the EPA and published a draft, “Regulation of Mosquito-Related Products,” for public comment in January 2017. Those comments were considered in issuing this final guidance.

As part of the Update to the Coordinated Framework for the Regulation of Biotechnology, the FDA, along with the EPA and the U.S. Department of Agriculture (USDA), committed to clarifying how the U.S. federal government intends to regulate genetically altered insects. This final guidance fulfills part of that overarching commitment.

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