Mosquito-Related Products

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.