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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).
Read entire press release.
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