U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products
  1. Regulatory Information

GUIDANCE DOCUMENT

CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products October 2017

Final

CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products

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).


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

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

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002