Docket Number:
FDA-2016-D-4482
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

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).

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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-4482.

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