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FDA Releases Draft Guidance for Regulation of Mosquito-Related Products (January 2017)

The Food and Drug Administration (FDA) has released a draft guidance to provide insight on mosquito-related products and their regulation. Health concerns regarding the spread of mosquito-borne illness including the Zika virus, have prompted FDA to address which products would be regulated by FDA or by the Environmental Protection Agency (EPA).

New Animal Drugs vs. Pesticide Products

FDA is the primary authority over regulations of the Food, Drug, and Cosmetics Act (FD&C Act), the primary drug regulation law. The FD&C Act defines drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

EPA is the primary agency providing oversight for regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the primary pesticide regulation law. FIFRA defines pesticides as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest…except that the term ‘Pesticide’ shall not include any article that is a ‘new animal drug’ within the meaning of section 321([v]) of title 21…”

New animal drugs pertain to substances used in or on mosquitoes in order to treat or prevent disease in humans or other animals and fall under FDA’s jurisdiction. This includes reducing viruses in the mosquito. In contrast, pesticides are substances used to control the physical population of mosquitoes, by killing them or reducing potential for reproduction and development and fall under EPA’s jurisdiction.

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