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U.S. Food and Drug Administration
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  3. Development & Approval Process
  4. Biotechnology Products at CVM: Animals and Animal Food
  5. Intentional Genomic Alterations (IGAs) in Animals
  6. Mosquito-Related Products
  1. Intentional Genomic Alterations (IGAs) in Animals

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 continues to have jurisdiction over mosquito-related products for other intended uses, such as to prevent, treat, mitigate or cure a disease. 

If you have questions about an animal biotechnology process or product, please contact the agency at AskCVM-Biotech@fda.hhs.gov. For information on other product types or for all other general inquiries, contact AskCVM@fda.hhs.gov. 

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