Contains Nonbinding Recommendations 
#236 
Clarification of FDA and EPA 
Jurisdiction Over Mosquito-Related 
Products 
Guidance for Industry 
Submit comments on this guidance at any time.  Submit written comments to the Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, 
Rockville, MD 20852.  Submit electronic comments on the guidance at 
https://www.regulations.gov/.  All written comments should be identified with the Docket No. 
FDA-2016-D-4482. 
For further information regarding this document, contact AskCVM@fda.hhs.gov. 
Additional copies of this guidance document may be requested from the Policy and Regulations 
Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish 
Place, Rockville, MD 20855, and may be viewed on the Internet at either 
https://www.fda.gov/AnimalVeterinary/default.htm or https://www.regulations.gov/. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
October 2017 
1  Contains Nonbinding Recommendations 
Table of Contents 
 
 
I.  INTRODUCTION ..................................................................................................... 3 
II.  BACKGROUND ........................................................................................................ 3 
A.  New Animal Drugs ........................................................................................... 3 
B.  Pesticides........................................................................................................... 4 
III.  DISCUSSION ............................................................................................................. 4 
A.  Scope of Guidance ............................................................................................ 4 
B.  FDA and EPA Jurisdiction Over Mosquito-Related Products ......................... 4 
1.Examples of New Animal Drugs  Regulated by FDA ................................. 5 
2.Example of Pesticide Products  Regulated by EPA ..................................... 6 
C.  Guidance for Sponsors/Manufacturers of Products Intended for use in 
Mosquitoes ........................................................................................................ 6 
IV.  CONTACT INFORMATION .................................................................................. 6 
 
2  Contains Nonbinding Recommendations 
Clarification of FDA and EPA Jurisdiction 
Over Mosquito-Related Products 
 
Guidance for Industry 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA 
or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA office 
responsible for this guidance as listed on the title page. 
 
I.  INTRODUCTION 
 
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). 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in the Agencys guidances means that something is suggested 
or recommended, but not required. 
 
II.  BACKGROUND 
 
Both FDA and EPA regulate products intended for use in or on animals.  FDA is charged with 
protecting the public health by, among other things, ensuring that animal drugs are safe and 
effective [21 U.S.C. 393(b)(2)(B)]; under FIFRA, EPA is charged with protecting human health 
and the environment by ensuring registered pesticide products, when used according to the label 
directions, result in no unreasonable adverse effects to man or the environment.  [7 U.S.C. 
136a(c)(5)]. 
 
A.  New Animal Drugs 
 
The FD&C Act defines the term drug as, among other things, 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. [21 U.S.C. 321(g)(1)].  With very limited exceptions for animal drugs that are 
generally recognized as safe and effective or are subject to a grandfather clause, the FD&C Act 
defines drugs that are intended for use for animals as new animal drugs.  As such, these drugs 
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are subject to applicable pre-market approval and/or other review requirements. [21 U.S.C. 
321(v); 21 U.S.C. 360b; 21 U.S.C. 360ccc; 21 U.S.C. 360ccc-1]. 
 
B.  Pesticides 
 
FIFRA defines the term pesticide to mean, in part, (1) 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...  [7 U.S.C. 136(u)].  Generally speaking, pesticides must be registered 
with EPA prior to distribution or sale, unless they are otherwise excluded or exempted from 
regulation (e.g., they meet the specific conditions or criteria in 40 CFR  152.6; or they qualify 
for an exemption as, for instance, a minimum risk pesticide under 40 CFR  152.25(f)). 
 
III.  DISCUSSION 
 
A.  Scope of Guidance 
 
This guidance provides information for industry and other stakeholders regarding regulatory 
oversight of mosquito-related products.  This guidance is important in light of the public health 
urgency of countering the spread of mosquito-borne disease, such as that caused by the Zika 
virus.  Vector control is a critical element of the effort to combat the spread of mosquito-borne 
disease.1   Novel mosquito control technologies have gained greater attention as an element of 
this effort; however, there has been some confusion with respect to FDAs and EPAs respective 
jurisdiction over such mosquito-related products. 
 
Given the public health implications of mosquito control, FDA, working collaboratively with 
EPA, is providing this guidance to clarify the regulatory oversight of mosquito-related products, 
including but not limited to those produced through biotechnology.2 
 
B.  FDA and EPA Jurisdiction Over Mosquito-Related Products3 
 
The FD&C Acts definition of drug includes 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. 21 
                                                 
1 See A Strategy for Integrating Best Practices with New Science to Prevent Disease Transmission by Aedes 
Mosquito Vectors, available online at: https://www.hsdl.org/?abstract&did=797520. 
 
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We also note that FDA, EPA, and USDA have committed to clarifying how the U.S. Federal Government intends to 
regulate genetically engineered insects. National Strategy for Modernizing the Regulatory System for Biotechnology 
Products, released by the White House Office of Science and Technology Policy, September 16, 2016. 
 
3 Developers may need to comply with additional requirements for import or interstate movement of certain 
mosquito-related products, including those contained in mosquitoes.  To ensure you are in compliance with 
applicable requirements, contact APHIS at 
https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/sa_contact_brs/ct_contact_brs; and CDC at 
https://www.cdc.gov/phpr/ipp/index.htm. 
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U.S.C. 321(g)(1).  However, mosquitoes, which are animals, also fall within the FIFRA 
definition of pest.4 
 
FIFRAs definition of pesticide includes any substance or mixture of substances intended for 
preventing, destroying, repelling, or mitigating any pest and any substance or mixture of 
substances intended for use as a plant regulator, defoliant, or desiccant.  7 U.S.C. 136(u).  
Pesticide products for mosquitoes, which are intended to prevent, destroy, repel, or mitigate 
mosquitoes, necessarily affect the structure or function of the body of the mosquito. 
 
Before 1975, FDA and EPA each had authority to regulate substances that controlled mosquito 
population if they met both the definition of "new animal drug" under the FD&C Act and the 
definition of "pesticide" under FIFRA.  Because of concern that this dual jurisdiction created 
regulatory burden and confusion about which Agency had primary jurisdiction, Congress 
amended FIFRAs definition of "pesticide" in 1975 to exclude any article that is a new animal 
drug within the meaning of the FD&C Act.  Since the FIFRA definition of pesticide was 
amended in 1975, EPA has registered, as pesticides, articles that control the population of 
mosquitoes by killing them or interfering with their reproduction, which is consistent with 
FDAs and EPAs general agreement that articles or categories of articles that control the 
population of mosquitoes are most appropriately regulated as pesticides.  This general agreement 
arises from a careful consideration of Congressional intent. 
 
Given this history, FDA is clarifying that the phrase articles (other than food) intended to affect 
the structure or any function of the body of man or other animals in the FD&C Acts drug 
definition [21 U.S.C. 321 (g)(1)(C)] does not include articles intended to function as pesticides 
by preventing, destroying, repelling, or mitigating mosquitoes for population control purposes.  
FDA believes that this interpretation is consistent with congressional intent and provides a 
rational approach for dividing responsibilities between FDA and EPA in regulating mosquito- 
related products. 
 
1.  Examples of New Animal Drugs  Regulated by FDA 
 
a.  Products intended to reduce the virus/pathogen load within a mosquito, including 
reduction in virus/pathogen replication and spread within the mosquito and/or reduction 
in virus/pathogen transmissibility from mosquitoes to humans. 
 
b.  Products intended to prevent mosquito-borne disease in humans or animals. 
   
                                                 
4 FIFRA defines a pest broadly to include (1) any insect, rodent, nematode, fungus, weed, or (2) any other form 
of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or 
other micro-organisms on or in living man or other animals). 7 U.S.C.  136(t).  EPAs regulation at 40 CFR 152.5 
expands in more specific detail on precisely what constitutes a pest for purposes of FIFRA. 
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2.  Example of Pesticide Products  Regulated by EPA 
 
Products intended to reduce the population of mosquitoes (for example, by killing them at 
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some point in their life cycle, or by interfering with their reproduction or development).  
 
C.  Guidance for Sponsors/Manufacturers of Products Intended for use in Mosquitoes 
 
FDA encourages sponsors of mosquito-related products, other than those that are intended to 
prevent, destroy, repel, or mitigate mosquitoes by controlling a mosquito population, to contact 
FDA early in the development process.  If a developer has a jurisdictional question, for example, 
which agency or agencies would have oversight of a mosquito-related product that is expressly 
intended for both mosquito population control and human disease suppression, the developer 
may contact either or both agencies via the contacts listed in section IV of this guidance.  The 
agencies will consult with each other on the jurisdictional question, as is already common 
practice.  The agencies may also suggest a joint meeting among EPA, FDA, and the sponsor to 
discuss appropriate pathways to market. 
 
IV.  CONTACT INFORMATION 
 
If you have any questions about how this interpretation may affect your regulated products, or 
products you have under development, you should contact the following FDA and EPA 
personnel: 
 
FDA: 
Laura R. Epstein 
Center for Veterinary Medicine (HFV-1) 
Food and Drug Administration 
7500 Standish Pl. Rockville, MD 20855 
301-796-8558 
   
                                                 
5 This is true whether the product is a traditional chemical product or involves a different technology (e.g., a 
recombinant DNA construct or bacteria intended to reduce the population of mosquitoes). 
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EPA: 
Elizabeth A. Milewski, Ph.D. 
Biopesticides and Pollution Prevention Division 
Office of Pesticide Programs 
Environmental Protection Agency 
1200 Pennsylvania Avenue NW Washington DC 20460 
703-347-0400 
 
Christopher A. Wozniak, Ph.D. 
Biopesticides and Pollution Prevention Division 
Office of Pesticide Programs 
Environmental Protection Agency 
1200 Pennsylvania Avenue NW Washington DC 20460 
703-308-4043 
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