Final guidance clarifying FDA and EPA jurisdiction over mosquito-related products

On October 5, 2017, the U.S. Food and Drug Administration (FDA) issued final Guidance for Industry which clarifies that mosquito-related products intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes, including those products produced by biotechnology, such as genetically engineered mosquitoes, will be regulated by the U.S. Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  FDA will continue to regulate (as drugs), under the Federal Food, Drug, and Cosmetic Act (FFDCA), mosquito-related products that are intended to prevent, treat, mitigate, or cure a disease.

Click here to view the final Guidance for Industry #236 – Clarification of FDA and EPA Jurisdiction over Mosquito-Related Products.