Regulation of Mosquito-Related Products; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #236 entitled ``Regulation of Mosquito-Related Products.'' This draft guidance provides information regarding regulatory oversight of mosquito-related products, defined as those articles for use in or on mosquitoes. We are clarifying circumstances under which such products are regulated by FDA as new animal drugs under the Federal Food, Drug, and Cosmetic Act (the 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).