On October 5, 2017, FDA issued final Guidance for Industry (GFI) #236 –Clarification of FDA and EPA Jurisdiction over Mosquito-Related Products, which 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 (including by an intent to reduce the level, replication or transmissibility of a pathogen in mosquitoes), 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. With the issuance of final guidance #236, Oxitec Ltd’s genetically engineered mosquito, with its proposed claim to control the population of wild-type aedes aegypti mosquitoes, now falls under EPA’s regulatory authority and all related regulatory questions should be directed to the EPA.
- Oxitec Mosquito - Final Environmental Assessment (PDF - 3MB)
- Oxitec Mosquito - Appendices to Final Environmental Assessment (PDF - 28.3MB)
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- Oxitec Mosquito - Finding of No Significant Impact (PDF - 198KB)
- Oxitec Mosquito - Draft Environmental Assessment (PDF - 33.3MB)
- Oxitec Mosquito - Preliminary Finding of No Significant Impact (PDF - 147KB)
- Final Guidance for Industry #236, Regulation of Mosquito-Related Products (PDF - 85KB)
- CVM Update: FDA Requests Comments on Documents Related to Certain Biotechnology and Mosquito-related Products