Oxitec Mosquito
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.
FDA Issues Final Guidance Clarifying FDA and EPA Jurisdiction over Mosquito-Related Products FDA finalized guidance to provide information on FDA and EPA jurisdiction over the regulation of mosquito-related products, including those produced through the use of biotechnology. FDA Releases Final Environmental Assessment for Genetically Engineered Mosquito FDA completed the environmental review for a proposed field trial to determine whether the release of Oxitec Ltd.’s GE mosquitoes will suppress the local Aedes aegypti mosquito population in the release area at Key Haven, FL. Oxitec Mosquito - Final Environmental Assessment (PDF - 3MB) [ARCHIVED]Oxitec Mosquito - Appendices to Final Environmental Assessment (PDF - 28.3MB) [ARCHIVED]
Persons using assistive technology may not be able to fully access information in this document. For assistance, please call 240-402-7002.Oxitec Mosquito - Finding of No Significant Impact (PDF - 198KB) [ARCHIVED]Oxitec Mosquito - Draft Environmental Assessment (PDF - 33.3MB) [ARCHIVED]Oxitec Mosquito - Preliminary Finding of No Significant Impact (PDF - 147KB) [ARCHIVED]- Final Guidance for Industry #236, Regulation of Mosquito-Related Products (PDF - 85KB)
This guidance provides information for industry regarding regulatory oversight of articles, including substances, for use in or on mosquitoes. - CVM Update: FDA Requests Comments on Documents Related to Certain Biotechnology and Mosquito-related Products
FDA released today three documents for public comment about steps the agency is taking to clarify its regulation of certain biotechnology and mosquito-related products.