Issue Date: August 27, 2025
Issued by: Center for Veterinary Medicine
Topic(s): New Animal Drug Application (NADA)
Status: Final
CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products
This guidance provides information for industry and other stakeholders regarding regulatory oversight of articles, including substances, for use in or on mosquitoes (“mosquito-related products”). We are providing this guidance to clarify circumstances under which such products are regulated by the Food and Drug Administration (FDA) as new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other circumstances under which such products are regulated by the Environmental Protection Agency (EPA) as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Download the Guidance Document
